HealthyPhase 1NCT06003829

A Study to Learn About the Tastes of Different Suspensions With the Study Medicine (PF-07923568) in Healthy Adult Participants.

A Phase 1 study testing Sinsunatovir and Bitrex in people with Healthy, run by Pfizer at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to learn about the tastes of different suspensions with the study medicine called PF-07923568 in healthy adult participants. In a suspension, the medicine is mixed with a liquid, usually water, in which it cannot dissolve and therefore remains intact in the form of small particles. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Sinsunatovir and Bitrex
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteBelgium
Study dates: 31 Jul 2023to 20 Sep 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male and female participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate and standard 12-lead electrocardiogram (ECG).
Body mass index (BMI) of 16-32 kg/m2; and a total body weight >45 kg

Who cannot join

Evidence or history of clinically significant hematological, renal, endocrine,pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Conditions that affect ability to taste eg, dysgeusia, respiratory infection, cold, etc.
History of hypersensitivity to the active compounds or to any inactive ingredients (excipients) contained in the formulations.
Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
A positive urine drug test at screening or admission.

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A positive serum pregnancy test at screening and/or positive urine/serum pregnancy test in woman/women of childbearing potential (WOCBP) at Day -1
Use of tobacco/nicotine containing products
Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants <60 years; and ≥150/90 mm Hg for participants ≥60 years old, following at least 5 minutes of supine rest.
Renal impairment as defined by an estimated glomerular filtration rate (eGFR) (units of mL/min/1.73m²) <60 mL/min(/1.73m²) based on 2021 chronic kidney disease epidemiology (CKD-EPI).
Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
Alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin (Bili) ≥ 1.05 × upper limit of normal (ULN). Participants with an elevated total bilirubin consistent with Gilbert's Disease should have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070

Other trials in Belgium

About this study

Official title: A RANDOMIZED, PHASE 1, SINGLE-BLIND, MULTI-PERIOD STUDY TO INVESTIGATE THE PALATABILITY OF PF-07923568 ORAL SUSPENSION IN DIFFERENT LIQUID VEHICLES IN HEALTHY ADULT PARTICIPANTS

This study is seeking for healthy participants who:

are aged 18 years of age or older.
can produce a baby must agree to use a highly effective method of birth control.
are confirmed to be healthy by some medical tests. This study can include both men and women.
have body mass index (BMI) of 16 to 32 kg/m2 and a total body weight of more than 45 kilograms.

Participants will take sisunatovir prepared in 5 different suspensions and bitrex over two days to see if they are good to taste. Participants will answer a questionnaire after tasting each suspension. The questionnaire will be completed for each suspension. The questionnaire asks participants to test each suspension at 4 different times after tasting and spitting out the suspension. At least 60 minutes will pass between tasting each suspension.

The total planned time period of participation is around 5 to 8 weeks. This includes the screening period of up to 28 days. Followed by first administration of study medicine. Then a 3 day in-patient stay at the study clinic. It also includes a follow-up phone call that happens 28-35 days after the final taste test.

Conditions: Healthy
Being tested: Sinsunatovir, Bitrex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SinsunatovirDrug
Single dose, to be spit out after tasting
BitrexOther
Single dose, to be spit out after tasting

Study groups in NCT06003829
Study group	Role	What they receive
Treatment A	Experimental	Not described Receives: Drug: Sinsunatovir
Treatment B	Experimental	Not described Receives: Drug: Sinsunatovir
Treatment C	Other	Comparator Receives: Other: Bitrex
Treatment D	Experimental	Not described Receives: Drug: Sinsunatovir
Treatment E	Experimental	Not described Receives: Drug: Sinsunatovir
Treatment F	Experimental	Not described Receives: Drug: Sinsunatovir

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 1
Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.
Measured: At 1 minute after tasting specified study formulation on Day 1
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 1
Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.
Measured: At 5 minutes after tasting specified study formulation on Day 1
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 1
Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.
Measured: At 10 minutes after tasting specified study formulation on Day 1
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 1
Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.
Measured: At 20 minutes after tasting specified study formulation on Day 1
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 2
Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.
Measured: At 1 minute after tasting specified study formulation on Day 2
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 2
Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.
Measured: At 5 minutes after tasting specified study formulation on Day 2
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 2
Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.
Measured: At 10 minutes after tasting specified study formulation on Day 2
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 2
Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.
Measured: At 20 minutes after tasting specified study formulation on Day 2

Secondary outcomes (3)

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE was an AE that occurred after initiation of study intervention (formulation) that was not present at the time of treatment start up to 35 days after administration of last study intervention (formulation).
Measured: Day 1 of receiving formulation up to 35 days after last formulation of the study (up to 37 days)
Number of Participants With Clinically Significant Laboratory Abnormalities
Laboratory analysis included were: hematology, chemistry and urinalysis. Clinically significance in laboratory abnormalities were judged by investigator.
Measured: 1 day prior to first formulation (Day -1) up to last formulation on Day 2 (up to 3 days)
Number of Participants With Clinically Significant Vital Signs Abnormalities
Vital signs included blood pressure (systolic and diastolic) and pulse rate. Clinically significance in vital sign abnormalities were judged by investigator.
Measured: Day 1 of receiving formulation up to last formulation on Day 2 (up to 2 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jul 202320 Sep 2023

First posted22 Aug 2023
Study start31 Jul 2023
Primary completion20 Sep 2023
Study completion20 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06003829
Sponsor's protocol ID: C5241014
Other IDs: 2023-504924-24-00, 2023
Status last verified: Sep 2024
First submitted: 26 Jul 2023
Last updated: 13 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A RANDOMIZED, PHASE 1, SINGLE-BLIND, MULTI-PERIOD STUDY TO INVESTIGATE THE PALATABILITY OF PF-07923568 ORAL SUSPENSION IN DIFFERENT LIQUID VEHICLES IN HEALTHY ADULT PARTICIPANTS
ClinicalTrials.gov ID: NCT06003829
Acronym / sponsor ID: C5241014
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 31 Jul 2023 (actual)
Primary completion: 20 Sep 2023 (actual)
Study completion: 20 Sep 2023 (actual)
First posted: 22 Aug 2023 (actual)
Results: Posted 13 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is seeking for healthy participants who:

are aged 18 years of age or older.
can produce a baby must agree to use a highly effective method of birth control.
are confirmed to be healthy by some medical tests. This study can include both men and women.
have body mass index (BMI) of 16 to 32 kg/m2 and a total body weight of more than 45 kilograms.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 6

Arm	Type	Receives
Treatment A	Experimental	Drug: Sinsunatovir
Treatment B	Experimental	Drug: Sinsunatovir
Treatment C	Other	Other: BitrexComparator
Treatment D	Experimental	Drug: Sinsunatovir
Treatment E	Experimental	Drug: Sinsunatovir
Treatment F	Experimental	Drug: Sinsunatovir

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Male and female participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate and standard 12-lead electrocardiogram (ECG).
Body mass index (BMI) of 16-32 kg/m2; and a total body weight >45 kg

Key exclusion criteria (12 listed)

Evidence or history of clinically significant hematological, renal, endocrine,pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Conditions that affect ability to taste eg, dysgeusia, respiratory infection, cold, etc.
History of hypersensitivity to the active compounds or to any inactive ingredients (excipients) contained in the formulations.
Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SinsunatovirSingle dose, to be spit out after tasting	Drug	Treatment A, Treatment B, Treatment D, Treatment E, Treatment F
BitrexSingle dose, to be spit out after tasting	Other	Treatment C

Primary outcome

Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 1
Time frame: At 1 minute after tasting specified study formulation on Day 1
Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 1
Time frame: At 5 minutes after tasting specified study formulation on Day 1
Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 1
Time frame: At 10 minutes after tasting specified study formulation on Day 1
Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 1
Time frame: At 20 minutes after tasting specified study formulation on Day 1
Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 2
Time frame: At 1 minute after tasting specified study formulation on Day 2
Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 2
Time frame: At 5 minutes after tasting specified study formulation on Day 2
Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 2
Time frame: At 10 minutes after tasting specified study formulation on Day 2
Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 2
Time frame: At 20 minutes after tasting specified study formulation on Day 2
Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.

3 secondary outcomes

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Day 1 of receiving formulation up to 35 days after last formulation of the study (up to 37 days)
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: 1 day prior to first formulation (Day -1) up to last formulation on Day 2 (up to 3 days)
Number of Participants With Clinically Significant Vital Signs Abnormalities
Time frame: Day 1 of receiving formulation up to last formulation on Day 2 (up to 2 days)

Results and safety

Results posted to the registry on 13 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Formulation A Then B Then D Then C Then A Then E Then None Then F	3	3
Formulation B Then C Then A Then D Then E Then F Then A Then None	3	3
Formulation C Then D Then B Then A Then F Then None Then E Then A	3	3
Formulation D Then A Then C Then B Then None Then A Then F Then E	3	3

Primary outcome: Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 1

Time frame: At 1 minute after tasting specified study formulation on Day 1. Mean (90% Confidence Interval). Unit: Units on a scale

Measure	Formulation A n = 12	Formulation B n = 12	Formulation C n = 12	Formulation D n = 12
Mouth Feel	80.3 (72.65 to 88.02)	49.4 (40.69 to 58.15)	54.0 (40.09 to 67.91)	48.5 (37.47 to 59.53)
Bitterness	80.2 (73.91 to 86.43)	49.8 (36.55 to 62.95)	59.5 (47.10 to 71.90)	49.4 (34.47 to 64.36)
Sweetness	25.8 (8.89 to 42.61)	36.3 (26.57 to 45.93)	16.3 (7.46 to 25.04)	28.3 (16.59 to 40.08)
Sourness	50.1 (35.25 to 64.92)	32.8 (23.49 to 42.18)	32.8 (16.65 to 49.01)	30.3 (17.85 to 42.82)
Saltiness	46.6 (30.18 to 62.99)	28.0 (17.18 to 38.82)	26.1 (13.18 to 38.99)	30.8 (18.46 to 43.20)
Tongue/Mouth Burn	27.5 (13.30 to 41.70)	21.3 (10.72 to 31.78)	14.8 (6.03 to 23.63)	18.3 (8.50 to 28.17)
Overall Liking	85.1 (76.58 to 93.59)	55.6 (43.51 to 67.65)	57.9 (45.23 to 70.60)	50.4 (36.49 to 64.35)

Population analysed: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Data was reported only for those formulations which were administered on Day 1.

Primary outcome: Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 1

Time frame: At 5 minutes after tasting specified study formulation on Day 1. Mean (90% Confidence Interval). Unit: Units on a scale

Measure	Formulation A n = 12	Formulation B n = 12	Formulation C n = 12	Formulation D n = 12
Mouth Feel	66.6 (56.85 to 76.31)	45.8 (33.91 to 57.59)	50.9 (39.47 to 62.36)	46.7 (32.36 to 60.97)
Bitterness	72.3 (61.87 to 82.63)	45.9 (37.18 to 54.66)	53.5 (42.36 to 64.64)	53.2 (40.82 to 65.52)
Sweetness	22.7 (9.28 to 36.05)	30.3 (18.94 to 41.56)	18.3 (8.72 to 27.95)	27.4 (14.88 to 39.95)
Sourness	43.8 (28.95 to 58.71)	30.3 (20.83 to 39.83)	28.9 (15.76 to 42.08)	27.7 (17.09 to 38.24)
Saltiness	34.5 (18.43 to 50.57)	23.0 (13.24 to 32.76)	24.9 (12.22 to 37.61)	24.5 (12.84 to 36.16)
Tongue/Mouth Burn	23.3 (10.50 to 36.16)	21.8 (11.07 to 32.60)	17.1 (7.42 to 26.75)	17.3 (7.37 to 27.13)
Overall Liking	78.3 (68.19 to 88.31)	53.3 (38.59 to 68.07)	52.3 (40.97 to 63.70)	49.4 (34.27 to 64.56)

Primary outcome: Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 1

Time frame: At 10 minutes after tasting specified study formulation on Day 1. Mean (90% Confidence Interval). Unit: Units on a scale

Measure	Formulation A n = 12	Formulation B n = 12	Formulation C n = 12	Formulation D n = 12
Mouth Feel	62.6 (50.44 to 74.72)	43.2 (31.29 to 55.04)	40.3 (32.23 to 48.27)	44.6 (29.45 to 59.71)
Bitterness	66.2 (52.84 to 79.49)	48.0 (39.71 to 56.29)	42.0 (34.50 to 49.50)	52.7 (36.62 to 68.72)
Sweetness	23.3 (8.96 to 37.71)	25.8 (13.87 to 37.63)	16.3 (7.09 to 25.41)	23.9 (9.52 to 38.32)
Sourness	42.8 (27.34 to 58.16)	29.3 (18.51 to 40.15)	24.6 (13.38 to 35.79)	18.8 (9.50 to 28.00)
Saltiness	34.6 (18.98 to 50.19)	22.3 (11.42 to 33.24)	21.1 (9.12 to 33.04)	22.1 (11.27 to 32.89)
Tongue/Mouth Burn	23.4 (11.20 to 35.63)	18.8 (8.54 to 28.96)	15.8 (6.09 to 25.57)	16.0 (5.18 to 26.82)
Overall Liking	70.7 (56.77 to 84.57)	53.2 (40.38 to 65.96)	42.5 (32.88 to 52.12)	51.0 (34.37 to 67.63)

Primary outcome: Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 1

Time frame: At 20 minutes after tasting specified study formulation on Day 1. Mean (90% Confidence Interval). Unit: Units on a scale

Measure	Formulation A n = 12	Formulation B n = 12	Formulation C n = 12	Formulation D n = 12
Mouth Feel	58.3 (45.28 to 71.39)	41.5 (28.32 to 54.68)	29.8 (20.42 to 39.08)	44.5 (28.50 to 60.50)
Bitterness	62.7 (48.64 to 76.69)	46.0 (35.17 to 56.83)	24.0 (15.55 to 32.45)	47.8 (31.64 to 64.03)
Sweetness	19.1 (7.53 to 30.64)	26.6 (14.90 to 38.26)	16.5 (8.20 to 24.80)	22.0 (8.62 to 35.38)
Sourness	40.4 (25.64 to 55.19)	26.3 (14.97 to 37.70)	19.5 (8.98 to 30.02)	26.3 (11.96 to 40.54)
Saltiness	33.8 (18.87 to 48.80)	18.9 (9.03 to 28.80)	18.8 (8.48 to 29.19)	21.3 (9.04 to 33.63)
Tongue/Mouth Burn	23.5 (10.16 to 36.84)	16.8 (7.33 to 26.17)	14.8 (5.59 to 24.08)	13.5 (4.11 to 22.89)
Overall Liking	69.4 (53.71 to 85.12)	49.4 (36.99 to 61.85)	34.7 (25.77 to 43.57)	46.8 (29.96 to 63.71)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 of receiving formulation up to 35 days after last formulation of the study (up to 37 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Formulation A	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Formulation B	0 of 12 (0%)	3 of 12 (25%)	0 of 12
Formulation C	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Formulation D	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Formulation E	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Formulation F	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sinsunatovir and Bitrex in people with Healthy, run by Pfizer at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 1 (time frame: At 1 minute after tasting specified study formulation on Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06003829.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.